Comet Capnograph Module
FDA 510(k) K941165 · Spacelabs, Inc.
510(k) numberK941165
Submission
- Device name
- Comet Capnograph Module
- Applicant
- Spacelabs, Inc.
Redmond, WA, US - Received
- March 11, 1994
- Decision date
- October 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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| K913038 | Spacelab Model 90845 PCMS Multidisclosure StationDSH · Traditional | 10/04/1991SE |
| K905065 | Defibrillator Lead AdapterLDD · Traditional | 04/12/1991SE |
| K910029 | Patient Care Management System ModificationDXK · Traditional | 01/31/1991SE |
| K896903 | First Medic Model 510LDD · Traditional | 12/27/1990SE |
| K904318 | Local Report GeneratorDXN · Traditional | 12/18/1990SE |
Questions and answers
When was Comet Capnograph Module cleared by the FDA?
Comet Capnograph Module (K941165) received a 510(k) decision of Substantially Equivalent on October 6, 1994, 209 days after the submission was received.
What is the product code of K941165?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.